Alpha Linolenic Acid-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults With Mild Cognitive Impairment: Targeting Cerebrovascular and Blood-brain Barrier Health
New trial tests ALA nutrition to protect memory in older adults with genetic risk
Plain English Summary
ALA-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults is a Phase 2 clinical trial sponsored by Michal Schnaider Beeri, Ph.D. studying Cognitive Dysfunction, Alzheimer Disease, Blood-Brain Barrier, Apolipoprotein E, Deficiency or Defect of, Brain Aging, Fatty Acids, Omega-3. This study tests if a special type of omega-3 fatty acid, found in flaxseed oil, can help prevent memory loss in older adults. It is for individuals aged 60 and older who have mild memory problems and carry a specific gene (APOE4) linked to higher Alzheimer's risk. Participants will take either a flaxseed oil supplement or a placebo (corn oil) daily for six months, with regular check-ups. Current treatments for Alzheimer's have limited benefits and significant side effects; this trial explores a potentially safer nutritional approach. The trial aims to enroll 20 participants.
Official Summary
This randomized, double-blind, placebo-controlled pilot trial will evaluate the effects of alpha-linolenic acid (ALA) supplementation on cognitive function, blood-brain barrier integrity, and brain vascular health in older adults with mild cognitive impairment and APOE4 genotype. By targeting the endogenous synthesis of docosahexaenoic acid (DHA) through ALA supplementation, the investigators aim to overcome the limitations of direct DHA supplementation, particularly in APOE4 carriers who exhibit low brain DHA levels and impaired blood-brain barrier function. This innovative approach offers a safe, cost-effective, and easily implementable therapeutic strategy for older adults at high risk for Alzheimer's dementia, especially APOE4 carriers, addressing a critical need given the limited cognitive benefits and significant adverse events of current amyloid-clearing drugs in this population.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 60 or older and have been diagnosed with mild memory loss that doesn't affect daily life. You must have at least one copy of the APOE4 gene, which will be checked with a blood test. You cannot join if you have been diagnosed with dementia, Alzheimer's disease, or other significant brain conditions, or have had a stroke. You also cannot join if you have a serious illness with a short life expectancy, are undergoing active cancer treatment, or have allergies to flaxseed or corn oil. This trial is studying Cognitive Dysfunction, Alzheimer Disease, Blood-Brain Barrier, Apolipoprotein E, Deficiency or Defect of, Brain Aging, Fatty Acids, Omega-3, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The study will measure changes in overall thinking and memory skills, as well as the health and function of the blood vessels in the brain and the barrier that protects it, to see if the supplement ma The specific primary outcome measures are: Change in global cognitive (score) function (Baseline and 6 months); Change in Blood-Brain Barrier Integrity - Permeability of the BBB (Baseline and 6 months); Levels of blood biomarkers of BBB Integrity (baseline and 6 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses a critical need for effective and safe ways to prevent cognitive decline, particularly in individuals with a genetic predisposition to Alzheimer's, by exploring a nutritional supp Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Cognitive Dysfunction, Alzheimer Disease, Blood-Brain Barrier, Apolipoprotein E, Deficiency or Defect of, Brain Aging, Fatty Acids, Omega-3, where improved treatment options are needed.
Investor Insight
This Phase 2 trial is investigating a novel nutritional intervention for a high-risk population, potentially offering a cost-effective preventative strategy for a condition with a large and growing ma Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this trial is right for you, especially considering your genetic risk and any memory concerns. You will need to take a supplement (either flaxseed oil or corn oil) every day for six months and attend study visits. A study partner who knows you well will also be asked to provide information about your daily functioning. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 20 participants
Interventions
- DRUG: Alpha-Linolenic Acid (2.6 g/day) — Participants in this group will take flaxseed oil that contains 2.6 grams of alpha-linolenic acid (ALA) each day for six months. The oil will be provided in 5 mL prefilled oral syringes prepared by the Rutgers Clinical Research Pharmacy. Participants will take one syringe daily in the morning with food. They may mix the oil with cold foods such as yogurt or applesauce but should not heat it. The ALA supplement is intended to improve cognitive and brain health by enhancing the body's natural pro
- DIETARY_SUPPLEMENT: Placebo Control Group — Participants in this group will take corn oil that does not contain ALA. The oil will be provided in the same 5 mL prefilled oral syringes as the active supplement and will look, taste, and smell similar to the ALA oil. Participants will take one syringe daily in the morning with food for six months. The placebo is used to compare effects against the ALA supplement and to maintain blinding for both participants and study staff.
Primary Outcomes
- Change in global cognitive (score) function (Baseline and 6 months)
- Change in Blood-Brain Barrier Integrity - Permeability of the BBB (Baseline and 6 months)
- Levels of blood biomarkers of BBB Integrity (baseline and 6 months)
Secondary Outcomes
- Episodic Memory (Baseline and 6 months)
- Executive Function (Baseline and 6 months)
- Cerebral Blood Flow (Baseline and 6 months)
- Brain Vascular Reactivity (Baseline and 6 months)
- White Matter Hyperintensity (WMH) (Baseline and 6 months)
Full Eligibility Criteria
Inclusion Criteria: * Age 60 years or older * Have amnestic Mild Cognitive Impairment (MCI) - memory problems that do not interfere with daily life. * Carry at least one APOE4 gene allele (determined by a blood test). * Be fluent in English or Spanish. * Have a study partner (family member or friend) who can provide information about daily function. * Have the ability to give informed consent and comply with study visits and procedures. Exclusion Criteria: * A diagnosis of dementia or any other brain disease that significantly affects thinking or memory (e.g., Alzheimer's disease, Parkinson's disease, schizophrenia, epilepsy, traumatic brain injury). * History of stroke or other major neurological condition. * Short life expectancy due to end-stage disease or other serious medical condition. * Active cancer treatment that could interfere with study participation. * Allergy or sensitivity to flaxseed oil or corn oil. * Current use of flaxseed, flax oil, or fish oil supplements more than once per week. * MRI contraindications, such as pacemakers, metallic implants, or severe claustrophobia. * Current or past history of prostate cancer, regardless of remission status, OR a prostate-specific antigen (PSA) level \> 20 ng/mL at screening. * Use of experimental Alzheimer's treatments (e.g., amyloid monoclonal antibodies) unless on a stable regimen as confirmed by the treating physician.
Trial Locations
- Rutgers - Institute for Health, New Brunswick, New Jersey, United States
Frequently Asked Questions
What is clinical trial NCT07392723?
NCT07392723 is a Phase 2 INTERVENTIONAL study titled "ALA-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults." It is currently recruiting and is sponsored by Michal Schnaider Beeri, Ph.D.. The trial targets enrollment of 20 participants.
What conditions does NCT07392723 study?
This trial investigates treatments for Cognitive Dysfunction, Alzheimer Disease, Blood-Brain Barrier, Apolipoprotein E, Deficiency or Defect of, Brain Aging, Fatty Acids, Omega-3. The primary condition under study is Cognitive Dysfunction.
What treatments are being tested in NCT07392723?
The interventions being studied include: Alpha-Linolenic Acid (2.6 g/day) (DRUG), Placebo Control Group (DIETARY_SUPPLEMENT). Participants in this group will take flaxseed oil that contains 2.6 grams of alpha-linolenic acid (ALA) each day for six months. The oil will be provided in 5 mL prefilled oral syringes prepared by the Rutgers Clinical Research Pharmacy. Participants will take one syringe daily in the morning with food. They may mix the oil with cold foods such as yogurt or applesauce but should not heat it. The ALA supplement is intended to improve cognitive and brain health by enhancing the body's natural pro
What does Phase 2 mean for NCT07392723?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT07392723?
This trial is currently "Recruiting." It started on 2025-01-12. The estimated completion date is 2027-10.
Who is sponsoring NCT07392723?
NCT07392723 is sponsored by Michal Schnaider Beeri, Ph.D.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07392723?
The trial aims to enroll 20 participants. The trial is currently recruiting and accepting new participants.
How is NCT07392723 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07392723?
The primary outcome measures are: Change in global cognitive (score) function (Baseline and 6 months); Change in Blood-Brain Barrier Integrity - Permeability of the BBB (Baseline and 6 months); Levels of blood biomarkers of BBB Integrity (baseline and 6 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07392723 being conducted?
This trial is being conducted at 1 site, including New Brunswick, New Jersey (United States).
Where can I find official information about NCT07392723?
The official record for NCT07392723 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07392723. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07392723 testing in simple terms?
This study tests if a special type of omega-3 fatty acid, found in flaxseed oil, can help prevent memory loss in older adults. It is for individuals aged 60 and older who have mild memory problems and carry a specific gene (APOE4) linked to higher Alzheimer's risk.
Why is this trial significant?
This trial addresses a critical need for effective and safe ways to prevent cognitive decline, particularly in individuals with a genetic predisposition to Alzheimer's, by exploring a nutritional supp
What are the potential risks of participating in NCT07392723?
The main risks are related to the supplements, such as mild digestive upset (like nausea or diarrhea) or allergic reactions. There's a small risk of interactions with other medications or supplements you might be taking. Some participants might experience claustrophobia or have issues with MRI scans if they have metal implants. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07392723?
Ask your doctor if this trial is right for you, especially considering your genetic risk and any memory concerns. You will need to take a supplement (either flaxseed oil or corn oil) every day for six months and attend study visits. A study partner who knows you well will also be asked to provide information about your daily functioning. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07392723 signal from an investment perspective?
This Phase 2 trial is investigating a novel nutritional intervention for a high-risk population, potentially offering a cost-effective preventative strategy for a condition with a large and growing ma This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will take either a flaxseed oil supplement or a placebo (corn oil) daily for six months, with regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.